MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; IMPLANT

Catalog Number 502-03-50D

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2015

Event Type  malfunction  

Event Description

Doctor was doing a direct anterior hip.It was time to implant the trident cup, ref #502-11-50d lot #49257401, so the cup impactor bolt, ref # 1440-2011 lot # er9ca4, from the da instrumentation was threaded into the cup and impacted into the patient using the curved cup bolt impactor, ref #1440-2010, from the da instrumentation.When the cup was seated, the doctor tried to remove the cup impactor bolt, but the whole cup spun.So he took the whole cup out and repeated the process to re-insert the cup.He, again, tried to remove the cup bolt impactor but the whole cup spun.He pulled out the trident cup and attempted to remove the cup impactor bolt from the cup, but we could not do so (this one i was able to untwist down in spd after the case and will be sending it in).We opened another trident cup, ref #502-11-50d lot #49496201, and repeated the process to implant this cup with the other cup bolt impactor from the da instrumentation, ref #1440-2011 lot# er9ca4.We could not get it to grip the bone so doctor made the decision to open a tritanium cup, ref #502-03-50d lot #mmek8p, and we repeated the implanting process using the second cup bolt impactor.When the cup was seated he tried to remove the cup impactor bolt and, again, the cup spun.So he pulled the tritanium cup out of the patient and attempted to remove the second cup impactor bolt, but, again, we could not do so (will be returned).We ended up implanting the trident cup that we opened second because we could not get the cup impactor bolts out of the other two cups.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding disassembly issues between the bolt and shell was reported.Conclusion: this event is related to a series of similar reported events where the impactor bolt cannot be dissociated from the associated shell.Capa pr was raised to further investigate these events.The preliminary investigation shows these events are associated with a wide variety of shells.Therefore, the shells did not contribute to the event and the impactor bolt will be further investigated.

Event Description

Doctor was doing a direct anterior hip.It was time to implant the trident cup, ref #502-11-50d lot #49257401, so the cup impactor bolt, ref # 1440-2011 lot # er9ca4, from the da instrumentation was threaded into the cup and impacted into the patient using the curved cup bolt impactor, ref #1440-2010, from the da instrumentation.When the cup was seated, the doctor tried to remove the cup impactor bolt, but the whole cup spun.So he took the whole cup out and repeated the process to re-insert the cup.He, again, tried to remove the cup bolt impactor but the whole cup spun.He pulled out the trident cup and attempted to remove the cup impactor bolt from the cup, but we could not do so (this one i was able to untwist down in spd after the case and will be sending it in).We opened another trident cup, ref #502-11-50d lot #49496201, and repeated the process to implant this cup with the other cup bolt impactor from the da instrumentation, ref #1440-2011 lot# er9ca4.We could not get it to grip the bone so doctor made the decision to open a tritanium cup, ref #502-03-50d lot #mmek8p, and we repeated the implanting process using the second cup bolt impactor.When the cup was seated he tried to remove the cup impactor bolt and, again, the cup spun.So he pulled the tritanium cup out of the patient and attempted to remove the second cup impactor bolt, but, again, we could not do so (will be returned).We ended up implanting the trident cup that we opened second because we could not get the cup impactor bolts out of the other two cups.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4551375
• MDR Text Key: 18266962
• Report Number: 0002249697-2015-00477
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 502-03-50D
• Device Lot Number: MMEK8P
• Other Device ID Number: STERILE LOT MSHME19A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 44